Infanrix is a trivalent purified vaccine designed to prevent tetanus, diphtheria and pertussis.
Release form and composition
Infanrix dosage form - suspension for i / m administration. Available in 0.5 ml in 1 ml glass syringes complete with or without needles, 1 or 10 syringes in a carton; 0.5 ml in glass vials with a volume of 3 ml complete with disposable plastic syringes or without them, 1, 10, 50 or 100 bottles per box.
Active substances (in 1 dose, component 0.5 ml):
- Tetanus toxoid - at least 40 IU;
- Diphtheria toxoid - at least 30 IU;
- Hemagglutinin filamentous - 25 µg;
- Pertussis toxoid - 25 µg;
- Pertactin - 8 mcg.
Auxiliary components: injectable water, sodium chloride, aluminum hydroxide, 2-phenoxyethanol (preservative).
Indications for use
- Primary vaccination of children from 3 months of age against whooping cough, tetanus and diphtheria;
- Revaccination of children previously immunized with three doses of whole-cell pertussis-diphtheria-tetanus or acellular pertussis-diphtheria-tetanus vaccine.
In the event that the beginning of the vaccination course was carried out with a whole-cell pertussis-diphtheria-tetanus vaccine, the administration of Infanrix is possible in the future and vice versa.
- Encephalopathy, which developed in the first 7 days after the previous vaccination with the vaccine, which includes the pertussis component (in this case, the vaccine continues with diphtheria-tetanus vaccine);
- Severe post-vaccination reaction to the previous infanrix injection (hyperemia at the injection site or edema more than 8 cm in diameter, elevated temperatures up to 40 ºС and more) or complication after previous vaccination (continuous crying lasting at least 3 hours, shock-like state or collapse within 48 hours after vaccination; convulsions, including those accompanied by fever, for 3 days after vaccination);
- Known hypersensitivity to any vaccine component;
- Hypersensitivity reactions after the previous injection of Infanrix.
Dosing and Administration
The vaccine is for intramuscular injections. The injection sites during the course of vaccination alternate.
A single dose is 0.5 ml. The primary vaccination course consists of 3 doses, they are administered, according to the National Vaccination Calendar of Russia, to children aged 3, 4.5 and 6 months. In 18 months spend revaccination.
Before injection, the drug is well shaken until a homogeneous, turbid liquid is formed and is carefully examined. If the appearance of the suspension changes, foreign particles or unmixed flakes are detected, the vaccine is not used.
Possible side effects of Infanrix:
- On the part of the lymphatic system: very rarely with revaccination - lymphadenopathy;
- On the part of the nervous system and psyche: often - irritability, drowsiness, unusual crying, mainly with revaccination - anxiety, only with the introduction of a revaccinating dose - a headache;
- On the part of the respiratory system: sometimes - rhinitis, pharyngitis, only with revaccination - cough and bronchitis;
- On the part of the digestive system: often - diarrhea, vomiting, mainly during revaccination - loss of appetite;
- Dermatological reactions: often - itching; sometimes rash; rarely - dermatitis, urticaria;
- General and local reactions: very often - redness of the injection site and edema up to 50 mm in diameter, increase in body temperature up to 38-39 ºC, mainly with revaccination - soreness and swelling more than 50 mm in diameter; sometimes - compaction and diffuse edema at the vaccination site, fever over 39.1 ºC, only with revaccination - a feeling of fatigue.
In the course of post-marketing observations, it was found that after the introduction of Infanrix also sometimes arise:
- Allergic reactions: angioedema, anaphylactoid, anaphylactic and hypersensitivity reactions;
- On the part of the respiratory system: apnea;
- On the part of the nervous system: convulsions (including with fever), shock-like state and collapse within 2-3 days after administration of the vaccine;
- Other: in rare cases - otitis media.
Data overdose Infanriks not provided.
Intravenous administration of Infanrix is absolutely contraindicated!
Before vaccination, the doctor must examine the child, study its history, paying particular attention to the previous administration of vaccines and the associated adverse reactions.
If a child has an acute illness with a fever, the administration of the vaccine is postponed. In case of an infectious disease that proceeds in a mild form, the vaccination is done after the normalization of body temperature.
To postpone the introduction of Infanrix until stabilization of the state follows even if the child has a progressive neurological disorder, including infantile spasms, progressive encephalopathy, uncontrolled epilepsy. The decision on the appointment of the vaccine with the pertussis component is made individually, taking into account the ratio of the expected benefits and possible risks.
Family history of convulsions and a history of febrile convulsions in a child’s history are not contraindications to vaccination, but require special attention.
We should not forget about the potential risk of apnea, therefore, it is necessary to control the respiratory function for 2-3 days after administration of the suspension during the course of primary vaccination of premature babies, especially if they have respiratory distress syndrome. However, vaccination of children in this group is necessary, it is impossible to refuse to conduct it or to postpone the vaccine.
In the vaccination room should be provided with the means necessary for the relief of a possible anaphylactic reaction. After the introduction of Infanrix for 30 minutes, the child should be under the supervision of a physician.
The immunization of children diagnosed with thrombocytopenia or other disorders of the blood coagulation system is carried out with caution, since i / m injection can lead to bleeding. For this reason, within 2 minutes you should press on the site of the vaccine without rubbing.
Infanrix can be prescribed for HIV-infected.
It is not always possible to achieve an adequate immune response when Infanrix is administered to patients with immunodeficiency states or undergoing immunosuppressive therapy.
According to the rules adopted in Russia, Infanrix can be administered on the same day with inactivated vaccines as a vaccine preventive schedule for epidemic indications and other vaccines for the National Vaccination Calendar. The only condition is that drugs should be administered in different parts of the body.
If necessary, Infanrix can be mixed with the Hiberix vaccine (against hemophilic infection type b). In this case, Infanrix replaces the solvent attached to Hiberiks.
Terms and conditions of storage
Store at a temperature of 2-8 ºС out of the reach of children.
Shelf life - 3 years.